Chery et al v. C. R. Bard, Inc.

Filing 236

MEMORANDUM OPINION AND ORDER The 70 MOTION by C. R. Bard, Inc. for Partial Summary Judgment on Plaintiffs Punitive Damages Claims is DENIED; and the 72 MOTION by C. R. Bard, Inc. for Partial Summary Judgment Against Plaintiffs is GRANTED in part and DENIED in part. The following specific causation Motions: 74 MOTION by C. R. Bard, Inc. to Limit the Opinions and Testimony of Sean Francis, M.D.; 76 MOTION by C. R. Bard, Inc. to Exclude Or Limit Certain Opinions And Testimony By John Mik los, M.D.; 78 MOTION by C. R. Bard, Inc. to Exclude or Limit Certain Opinions and Testimony by Jerry G. Blaivas, M.D.; 80 MOTION by C. R. Bard, Inc. to Exclude Or Limit Certain Opinions and Testimony of Dr. Bruce A. Rosenzweig; 82 MOTION b y C. R. Bard, Inc. to Exclude or Limit Certain Opinions and Testimony of Donald R. Ostergard, M.D.; 84 MOTION by C. R. Bard, Inc. to Exclude or Limit Certain Opinions and Testimony By Lennox Hoyte, M.D.; 86 MOTION by C. R. Bard, Inc. to Exclude The Opinions And Testimony Of Bernd Klosterhalfen, M.D.; 88 MOTION by C. R. Bard, Inc. to Limit the Opinions and Testimony of Abraham Morse, M.D.; 89 MOTION by C. R. Bard, Inc. to Limit The Opinions and Testimony of Daniel S. Elliott, M.D.; [ 93] MOTION by C. R. Bard, Inc. to Exclude, or in the Alternative Limit, the Opinions and Testimony of Kimberly H. Allison, M.D.; 95 MOTION by C. R. Bard, Inc. to Limit the Opinions and Testimony of Keith Reeves, M.D.; 97 MOTION by C. R. Bard, Inc. to Exclude or Limit Certain Opinions and Testimony by Garth Wilkes, Ph.D.; 99 MOTION by C. R. Bard, Inc. to Exclude Or Limit Certain Opinions And Testimony By Anthony Brennan, Ph.D.; 101 MOTION by C. R. Bard, Inc. to Exclude Or Limit Certa in Opinions and Testimony by Ahmed El-Ghannam Ph.D.; 103 MOTION by C. R. Bard, Inc. to Exclude Or Limit Certain Opinions And Testimony of Julia Babensee, Ph.D.; 105 MOTION by Dolores Chery, Joel Chery to Exclude Opinions and Testimony of David F. Feigal, Jr., M.D., M.P.H., and Brief in Support; 106 MOTION by Dolores Chery, Joel Chery to Exclude Opinions and Testimony of John G. Heller, M.D., and Brief in Support; 107 MOTION by Dolores Chery, Joel Chery to Exclude Opinions and Testi mony of Donna-Bea Tillman, Ph.D., M/P.A., and Brief in Support; 108 MOTION by Dolores Chery, Joel Chery to Exclude Opinions and Testimony of Christine T. Wood, Ph.D.; 109 MOTION by Dolores Chery, Joel Chery to Exclude Opinions and Testimony of Peter Rosenblatt, M.D., and Brief in Support; 110 MOTION by Dolores Chery, Joel Chery to Exclude Opinions and Testimony of Marta Villaraga, Ph.D., and Brief in Support; 111 MOTION by Dolores Chery, Joel Chery to Exclude Opinions and Testimony of Maureen Reitman, Sc.D. and Brief in Support; 113 MOTION by C. R. Bard, Inc. to Exclude or Limit Certain Opinions and Testimony of Colleen Fitzgerald, M.D.; 116 MOTION by Dolores Chery, Joel Chery to Exclude the Opinions and Testimony of Nat han Guerette, M.D. on the Adequacy of Defendants' Warnings and Standard of Care Issues and Brief in Support; 119 MOTION by Dolores Chery, Joel Chery to Exclude Dr. Matthew Clark's Specific Causation Opinion Concerning Dolores Chery with Incorporated Memorandum of Law; 120 MOTION by Dolores Chery, Joel Chery to Exclude the Testimony of Carol Glowacki, M.D.; 122 DAUBERT MOTION by Dolores Chery, Joel Chery to Exclude Opinions of Dr. Michael Kennelly and Memorandum of Law; 185 MOTION by C. R. Bard, Inc. to Limit the Opinions and Testimony of Alan Garely, M.D.; 187 MOTION by C. R. Bard, Inc. to Exclude or Limit the Opinions and Testimony of Amir Shariati, M.D., and Memorandum in Support; 188 MOTION by Dolores Chery, Joel Chery to Exclude Certain General Opinions and Testimony of Douglas Van Drie, M.D., and Brief in Support; 189 MOTION by Dolores Chery, Joel Chery to Exclude Certain General Opinions and Testimony of Matthew Clark, M.D., and Brief in Support; 190 MOTION by Dolores Chery, Joel Chery to Exclude Opinions and Testimony of C.R. Bard, Inc.'s Physician Expert Thomas Giudice, M.D., and Brief in Support; 191 MOTION by Dolores Chery, Joel Chery to Exclude Certain Opinions and Testimony o f C.R. Bard, Inc's Non-Retained Corporate Expert Laura Bigby., and Brief in Support; 192 MOTION by Dolores Chery, Joel Chery to Exclude Certain Opinions and Testimony of C.R. Bard, Inc.'s Non-Retained Corporate Expert Roger Darois., and Brief in Support; 193 MOTION by Dolores Chery, Joel Chery to Exclude Exclude Certain Opinions and Testimony of C.R. Bard, Inc.'s Non-Retained Corporate Expert John Deford., and Brief in Support; 194 MOTION by Dolores Chery, Joel Chery t o Exclude Exclude Certain Opinions and Testimony of C.R. Bard, Inc.'s Non-Retained Corporate Expert Adam Silver and Brief in Support; 195 MOTION by Dolores Chery, Joel Chery to Exclude Exclude Certain Opinions and Testimony of C.R. Bard, Inc& #039;s Non-Retained Corporate Expert Michele Davis and Brief in Support; 196 MOTION by Dolores Chery, Joel Chery to Exclude Exclude Certain Opinions and Testimony of C.R. Bard, Inc.'s Non-Retained Corporate Expert John Knorpp and Brief in Sup port; 197 MOTION by Dolores Chery, Joel Chery to Exclude Certain Opinions and Testimony of C.R. Bard, Inc.'s Non-Retained Corporate Expert Mary Mayo and Brief in Support; 198 MOTION by Dolores Chery, Joel Chery to Exclude Certain Opinion s and Testimony of C.R. Bard, Inc.'s Non-Retained Corporate Expert Scott Robirds and Brief in Support; 199 MOTION by Dolores Chery, Joel Chery to Exclude the Testimony of Khush Mittal, M.D.; 200 MOTION by C. R. Bard, Inc. to Exclude or Lim it Certain Opinions and Testimony of Brian Raybon, M.D.; 201 MOTION by Dolores Chery, Joel Chery to Exclude Opinions and Testimony of Robert H. Young, M.D., and Brief in Support, to the extent that the parties seek relief that is consistent with this Memorandum Opinion & Order, are GRANTED in part. In all other respects, the parties motions are RESERVED in part. Signed by Judge Joseph R. Goodwin on 3/21/2017. (cc: counsel of record; any unrepresented party) (kp)

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
CHARLESTON DIVISION

DOLORES CHERY, et al.,
Plaintiffs,
v.

Civil Action No. 2:12-cv-8208

C. R. BARD, INC.,
Defendant.
MEMORANDUM OPINION AND ORDER
Pending before the court are all remaining pretrial motions. All are ripe for
adjudication.
I.

Background
This case resides in one of seven MDLs assigned to me by the Judicial Panel

on Multidistrict Litigation concerning the use of transvaginal surgical mesh to treat
pelvic organ prolapse (“POP”) and stress urinary incontinence (“SUI”). In the seven
MDLs, there are more than 58,000 cases currently pending, approximately 7,000 of
which are in the Bard MDL, MDL 2187. In an effort to efficiently and effectively
manage this MDL, I decided to conduct pretrial discovery and motions practice on an
individualized basis so that once a case is trial-ready (that is, after the court has ruled
on all Daubert motions and summary judgment motions, among other things), it can
then be promptly transferred or remanded to the appropriate district for trial. To this

end, I ordered the plaintiffs and defendant to each select 50 cases, which would then
become part of a “wave” of cases to be prepared for trial and, if necessary, remanded.

See Pretrial Order (“PTO”) # 102, No. 2:10-md-2187 [ECF No. 729]. This selection
process was completed twice, creating two waves of 100 cases, Wave 1 and Wave 2.
Thereafter, I entered orders on subsequent waves. Ms. Chery’s case was selected as
a Wave 2 case by the plaintiffs. PTO # 118, No. 2:10-md-2187 [ECF No. 841].
II.

Legal Standards
a. Summary Judgment
To obtain summary judgment, “the movant must show that there is no genuine

dispute as to any material fact and that the movant is entitled to judgment as a
matter of law.” Fed. R. Civ. P. 56(a). In turn, to avoid summary judgment, the
nonmovant must offer some “concrete evidence from which a reasonable juror could
return a verdict” in his or her favor. Anderson v. Liberty Lobby, Inc., 477 U.S. 242,
256 (1986).
b. Choice of Law
Under 28 U.S.C. § 1407, this court has authority to rule on pretrial motions in
MDL cases. To determine the applicable state law for a dispositive motion, the court
generally refers to the choice-of-law rules of the jurisdiction where the plaintiff first
filed her claim. See In re Air Disaster at Ramstein Air Base, Ger., 81 F.3d 570, 576
(5th Cir. 1996); In re Air Crash Disaster Near Chi., Ill., 644 F.2d 594, 610 (7th Cir.
1981); In re Digitek Prods. Liab. Litig., MDL No. 2:08-md-01968, 2010 WL 2102330,
at *7 (S.D. W. Va. May 25, 2010).

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If a plaintiff files her claim directly into the MDL in the Southern District of
West Virginia, as the plaintiffs did here, I consult the choice-of-law rules of the state
in which the implantation surgery took place—in this case, Florida. See Sanchez v.

Bos. Sci. Corp., No. 2:12-cv-05762, 2014 WL 202787, at *4 (S.D. W. Va. Jan. 17, 2014)
(“For cases that originate elsewhere and are directly filed into the MDL, I will follow
the better-reasoned authority that applies the choice-of-law rules of the originating
jurisdiction, which in our case is the state in which the plaintiff was implanted with
the product.”).
For tort claims, Florida generally applies the Restatement (Second) of Conflict
of Laws (Am. Law Inst. 1971). Bishop v. Fla. Specialty Paint Co., 389 So. 2d 999, 1001
(Fla. 1980). Under section 145 of the Restatement (Second) of Conflict of Laws, the
court must apply the law of the state with the most significant relationship to the
occurrence and the parties. Here, the plaintiff resides in Florida, and the product was
implanted in Florida. The parties agree, as do I, that Florida law applies to this case.
Accordingly, I will apply Florida law.
c. Daubert Motions – Specific Causation
Expert testimony is admissible if the expert is qualified and if his or her expert
testimony is reliable and relevant. Fed. R. Evid. 702; see also Daubert v. Merrell Dow

Pharm., Inc., 509 U.S. 579 (1993). An expert may be qualified to offer expert
testimony based on his or her “knowledge, skill, experience, training, or education.”
Fed. R. Evid. 702.
In the context of specific causation expert opinions, the Fourth Circuit has held

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that “a reliable differential diagnosis provides a valid foundation for an expert
opinion.” Westberry v. Gislaved Gummi AB, 178 F.3d 257, 262–63 (4th Cir. 1999). “A
differential diagnosis that fails to take serious account of other potential causes may
be so lacking that it cannot provide a reliable basis for an opinion on causation.” Id.
at 265. However, an expert’s causation opinions will not be excluded “because he or
she has failed to rule out every possible alternative cause of a plaintiff's illness.” Id.
At bottom, the court has broad discretion to determine whether expert testimony
should be admitted or excluded. Cooper v. Smith & Nephew, Inc., 259 F.3d 194, 200
(4th Cir. 2001).
III.

Discussion
a. Bard’s Motion for Summary Judgment [ECF No. 72]

Bard’s Motion for Summary Judgment [ECF No. 72] is GRANTED in part as
to the following conceded claims: manufacturing defect and breach of express and
implied warranties.
For the following reasons, Bard’s Motion for Summary Judgment [ECF No. 39]
is also GRANTED in part as to the following claims: negligent inspection, marketing,
labeling, packaging, and selling. “To state a claim for negligence under Florida law,
a plaintiff must allege that the defendant owed the plaintiff a duty of care, that the
defendant breached that duty, and that the breach caused the plaintiff to suffer
damages.” Lewis v. City of St. Petersburg, 260 F.3d 1260, 1262 (11th Cir. 2001); See

also Payne v. C. R. Bard, Inc., No. 6:11-cv-1582, 2014 WL 1887297, at *2 (M. D. Fla.
2014).

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Bard contends that the plaintiffs’ claims for negligent inspection, packaging,
marketing, and selling of the Align fail for lack of evidence. The plaintiffs argue that
Bard misconstrues the nature of their negligence argument, and that their
allegations regarding the inspection, marketing, labeling, packaging, and selling of
the Align comprise part of their general negligence claim, rather than distinct
theories of recovery. In short, the plaintiffs assert that Bard failed to adequately study
or test its mesh products, including the Align, to determine if the products were
adequately safe.
A review of the plaintiffs’ Count I in the Master Complaint, Master Compl. ¶¶
62–67, No. 2:10-md-2187 [ECF No. 199], reveals that the plaintiff asserted three
distinct negligence theories under “Count I.” The bulk of the Count I allegations make
claims for negligent failure to warn and negligent design defect. The other negligence
allegations posit that Bard was “negligent . . . in designing, manufacturing,
marketing, labeling, packaging, and selling” the Align. Id. at ¶ 64. Thus, the plaintiffs’
concern that Bard is misconstruing the plaintiffs’ negligence claim are meritless;
Bard simply chose to address the plaintiffs’ different theories of negligence separately.
However, apart from reciting allegations that form the plaintiffs’ failure to warn and
design defect claims, the plaintiffs do not offer sufficient support to create a genuine
dispute that Bard breached a legal duty that caused the plaintiffs’ injuries in its
“inspection, marketing, labeling, packaging, or selling” of the Align. Accordingly,
Bard’s Motion on these points is GRANTED.
After considering the parties’ proffered arguments and evidence, I FIND that

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genuine disputes of material fact exist regarding the plaintiffs’ remaining claims.
Accordingly, to the extent Bard’s Motion challenges any other claims, the Motion is
DENIED.
b. Bard’s Motion for Partial Summary Judgment [ECF No. 70]
The question of whether a plaintiff is entitled to punitive damages often
involves an interlocking web of factual determinations respecting the defendant’s
conduct. The evidentiary record is frequently muddled enough on the point that
genuine issues of material fact remain. That is the case here. Consequently, Bard is
not, at least at this stage of the case, entitled to judgment as a matter of law on the
punitive damages claim. Thus, the Motion for Partial Summary Judgment [ECF No.
70] is DENIED.
c. Specific Causation Daubert Motions [ECF Nos. 74, 76, 78, 80, 82, 84, 86,
88, 89, 93, 95, 97, 99, 101, 103, 105, 106, 107, 108, 109, 110, 111, 113,
116, 119, 120, 122, 185, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196,
197, 198, 199, 200, 201, 232]
Many of the Daubert motions filed in this MDL raise the same or similar
objections. One particular issue has been a staple in this litigation, so I find it best to
discuss it in connection with every expert. I have repeatedly excluded evidence
regarding the FDA’s section 510(k) clearance process in these MDLs, and will
continue to do so in these cases, a position that has been affirmed by the Fourth
Circuit. In re C. R. Bard, Inc., 81 F.3d 913, 921–23 (4th Cir. 2016) (upholding the
determination that the probative value of evidence related to section 510(k) was

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substantially outweighed by its possible prejudicial impact under Rule 403). Because
the section 510(k) clearance process does not speak directly to safety and efficacy, it
is of negligible probative value. See id. at 920 (“[T]he clear weight of persuasive and
controlling authority favors a finding that the 510(k) procedure is of little or no
evidentiary value.”). Delving into complex and lengthy testimony about regulatory
compliance could inflate the perceived importance of compliance and lead jurors “to
erroneously conclude that regulatory compliance proved safety.” Id. at 922.
Accordingly, expert testimony related to the section 510(k) process, including
subsequent enforcement actions and discussion of the information the defendant did
or did not submit in its section 510(k) application, is EXCLUDED. For the same
reasons, opinions about the defendant’s compliance with or violation of the FDA’s
labeling and adverse event reporting regulations are EXCLUDED. In addition to
representing inappropriate legal conclusions, such testimony is not helpful to the jury
in determining the facts at issue in these cases and runs the risk of misleading the
jury and confusing the issues. Insofar as any Daubert motion in this case challenges
the FDA-related testimony discussed here, the motions are GRANTED.
The parties have identified more experts than can ever be called in a trial of
any reasonable length. In this case alone, the parties have filed forty-four separate

Daubert motions. Thus, I have considered principles of good judicial efficiency and
proper management of judicial resources, and I now determine that substantive
rulings on these motions are better suited for cases that will actually be tried on the
merits. Accordingly, all remaining Daubert challenges to expert testimony in this

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case are RESERVED for trial.
IV.

Conclusion
The court ORDERS that:
•

Bard’s Motion for Summary Judgment [ECF No. 72] is GRANTED in
part and DENIED in part;

•

Bard’s Motion for Partial Summary Judgment [ECF No. 70] is
DENIED; and

•

The specific causation Motions [ECF Nos. 74, 76, 78, 80, 82, 84, 86, 88,
89, 93, 95, 97, 99, 101, 103, 105, 106, 107, 108, 109, 110, 111, 113, 116,
119, 120, 122, 185, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196,
197, 198, 199, 200, 201, 232], to the extent that the parties seek relief
that is consistent with this Memorandum Opinion & Order, are
GRANTED in part. In all other respects, the court ORDERS that the
parties’ motions are RESERVED in part.

The court DIRECTS the Clerk to send a copy of this Order to counsel of record and
any unrepresented party.
ENTER:

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March 21, 2017